Together on the trail to the summit

Who We Are

Ron Filler, PhD

Founder/ President

As Founder and Head of DDC, Ron brings to DDC extensive experience in many areas of basic life sciences and in toxicology. Ron received a PhD from the Fels Research Institute in the Temple University School of Medicine. Ron went onto becoming Unit Head of Teratogenesis at the Biology Division of the Oak Ridge National Laboratory in Tennessee and later the Head of a Teratology Section at the FDA’s laboratory in Arkansas, the National Center for Toxicological Research. Afterwards, Ron worked at major Contract Research Organizations in the US as Study Director of Toxicology and as Director of Reproduction and Teratology with special expertise in male fertility assessment. Ron was later recruited into the pharmaceutical industry at American Cyanimide’s Lederle Laboratories in Pearl River, New York and then as Director of Toxicology/Pharmacology at Forest Laboratories.

Ron has been s involved in developing international licensing and drug development collaborations with various partners. He was an active participant and contributor to the successful approval of several NDAs one of which was the blockbuster SSRI drug Celexa®. After gaining extensive regulatory and drug development experience in a broad range of therapeutic indications, Ron formed DDC to offer high quality regulatory and scientific services to the pharmaceutical, biopharmaceutical and generic drug industries. Ron was also Consultant to the FDA on Special Scientific/Regulatory Initiatives.

Ron has published over 40 scientific publications and two chapters in toxicology/pharmacology review texts.

Angus McLean, PhD

Vice President, Scientific Affairs

Angus has over 30 years’ experience in the pharmaceutical industry. He has specialized in pharmaceutical development, clinical development programs and regulatory submissions. His experience in clinical development involves clinical protocol design, budgeting, pharmacokinetic data analysis and interpretation. Angus has been involved in bioanalytical method development, validation and pharmacokinetic support of preclinical and clinical programs (Phases 1 to 4). Angus has performed biopharmaceutical reviews, patent literature reviews and medical writing, He is actively engage in performing preclinical pharmacokinetic evaluations, bioavailability and bioequivalence investigations, and in vitro/in vivo correlations.

Angus obtained his PhD at the University of Strathelyde (Scotland). Afterwards, he advanced drug metabolism research, both preclinical and clinical, at the Marie Curie Institute, the University of Surrey, and the Imperial College in England. Angus came to the United States in 1981 where he continued his research at the Drug Dynamics Institute at the University of Texas in Austin. Angus made his transition into the pharmaceutical industry as a Senior Analytical Chemist with Adria Laboratories and then onto a succession of more senior positions with Schering Plough, Pharmavene and Shire Laboratories.

Angus has 23 scientific articles published in peer reviewed journals.

Abraham Nyska, DVM, Diplomat ECVP, Fellow IATP

Head, Toxicologic Pathology

Prof. Nyska is an expert in toxicologic pathology. Abraham holdins two diplomas
and formal recognition in toxicologic pathology, reflecting the highest recognition
by the most highly-regarded international professional organizations. These
formal professional recognitions are very relevant and important to regulatory
agencies.

His credential include the following: Diplomate of the European College of Veterinary Pathologist , Fellow of the International Academy of Toxicologic Pathology, and is a Visiting Full Professor of Pathology, Sackler School of Medicine, Tel Aviv University.

Abraham has more than 37 years’ experience in evaluation and pre-clinical
risk assessment regarding safety-related toxicologic and experimental pathology
of chemicals, drugs, medical devices and stem cells. He worked for 10 years as a staff scientist and expert in Toxicologic Pathology at National Toxicology Program (NTP) of the National Institute of Health (NIH), followed by 8 year as an NTP Consultant. Dr. Nyska provides peer review toxicological services.

Abraham serves as an Associate Editor of “Toxicologic Pathology”. He has
strong research-oriented attitude and vast collaboration with top federal research
institutes (i.e., NIH, EPA) and academic institutes, with more than 411
publications in peer-reviewed journals. Professor Nyska is a consultant in Toxicologic Pathology to pharmaceutical companies, CRO’s, and governmental institutes in Israel, Europe, India and the USA.

Roustem Saiakhov, PhD

External Expert Resource, Computational Chemistry and Cheminformatics

Dr. Roustem Saiakhov is president of MultiCASE, Inc. His involvement with MultiCASE started in the year of 2000.

Native of Russia, Roustem was awarded a Ph.D. in 1991 through the Kazan State of University, where he studied the quantitative structure-activity relationship of complex elementoorganic compounds. He relocated to the United States in 1997. He has over 20 years of experience in teaching and research.

Roustem’s area of expertise includes cheminformatics, molecular modeling, QSAR, organic and computational chemistry and computational toxicology. In the past several years, Roustem was also involved in the risk assessment and safety consulting services. Roustem has been principal investigator on a number of grant projects and has over 100 scientific publications and presentations.

He speaks 3 languages: Russian, Polish and English.